Neoplasms

Nervous System Diseases

All Conditions

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

All patients enrolled in the study will prepare for surgery as per standard neurosurgical indications, procedures and institution protocols. At the time of the anesthesia induction, with the patient under general anesthesia, Fluorescein Sodium 10% (100mg/1mL) at a dose of 3-20 mg/kg will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used). For vascular lesions, fluorescein sodium 10% (100mg/1mL) will be injected and used to assess its application after the conventional methods have confirmed the exclusion of the aneurysm. No patient's care will be affected by the results of the Fluorescein angiography.

Fluorescein Sodium

Aaron A Cohen, MD, MSc

The purpose of this study is to evaluate the effectiveness of using Fluorescein Sodium and the Yellow 560 microscope to aid in treatment of intracranial tumors and vascular lesions.

The purpose of this study is to evaluate the effectiveness of using Fluorescein Sodium and the Yellow 560 microscope to aid in treatment of intracranial tumors and vascular lesions. The objectives of this study aim to investigate the use of Fluorescein in assisting with evaluating complete tumor removal and thorough treatment of intracranial vascular lesions as well as tumor biopsy procedures. The hypothesis is that Fluorescein Sodium will help surgeons better identify residual tumor and vascular lesions and its use will allow surgeons to obtain better surgical results and prognostic outcomes.

Yellow 560 Microscope for Intraoperative Visualization of Fluorescein Stained Intracranial Lesions

We will perform fluorescein fluorescence/angiography at surgery and assess if fluorescence reveals any residual tumor or vascular lesion (aneurysm, arteriovenous malformation, or arteriovenous fistula) following surgical intervention. For subjects with brain tumors we will then perform a regular postoperative MRI and assess if there was any residual tumor and measure the accuracy of fluorescein fluorescence to assess the amount of the residual tumor seen on the postoperative MRI. Similarly, for the aneurysms or other vascular lesions, we will perform a regular postoperative angiogram and assess the accuracy of fluorescein angiography results in estimating the amount of residual lesion.

Sentara Norfolk General Hospital

Indiana University

Neurosurgeon

Age, Categorical

Sex: Female, Male

Aaron Cohen-Gadol, MD, MSc

Concordance

Nonconcordance

Unable to reliably assess

Concordance Between Surgical Impression of Residual Lesion and Appearance on Post-operative Imaging

Overall Study

Rare Diseases

Adenoma

Adenolymphoma

Adenoma, Pleomorphic

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Warthin Tumor

Subjects undergoing parotid surgery for benign conditions will have fluorescein sodium administered intravenously after induction, and fluorescence imaging will be performed to visualize nerves intraoperatively

Intravenous administration of 1 mg/kg. If initial dosing is insufficient, additional doses may be administered up to a total of 3 mg/kg

Tulio Valdez, MD

The purpose of this study is to see if there is benefit in using an IV contrast (sodium fluorescein) called AK-Fluor® to identify nerves during head and neck surgery.

Experimental: Fluorescein sodium during surgery

Subjects undergoing parotid surgery for benign conditions will have fluorescein sodium administered intravenously after induction, and fluorescence imaging will be performed to visualize nerves intraoperatively

Identification of Nerves Using Fluorescein Sodium

Intraoperative Nerve Identification With Fluorescein Sodium

Surgeon assessment of fluorescence correlation with electrostimulation using a Likert-style rating from 1-4 where 1=No correlation; 2=Some correlation; 3=Good correlation; 4=Excellent correlation

Survey of surgeon visual assessment of nerve under white light compared to fluorescence using a Likert-style rating from 1-4 where 1=No correlation; 2=Some correlation; 3=Good correlation; 4=Excellent correlation.

Ratio of nerve fluorescence intensity compared to background fluorescence intensity

Average dose of sodium fluorescein administered in mg/kg

Amount of time (in minutes) to nerve fluorescence after sodium fluorescein adminstration

Stanford University

Professor of Otolaryngology

Ear, Nose, and Throat Diseases

Paraganglioma

Neurilemmoma

Meningioma

Neuroma, Acoustic

Neuroma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Nerve Sheath Neoplasms

Neoplasms, Nerve Tissue

Peripheral Nervous System Neoplasms

Vestibulocochlear Nerve Diseases

Retrocochlear Diseases

Ear Diseases

Otorhinolaryngologic Diseases

Otorhinolaryngologic Neoplasms

Cranial Nerve Diseases

Paragangliomas 1

Schwannoma

Acoustic Neuroma

Neuroendocrine Tumor

Neuroepithelioma

Subjects undergoing clinically planned vestibular schwannoma, Meningioma, Head and Neck Paraganglioma, or Head and Neck Schwannoma, removal surgery will have contrast agent fluorescein sodium administered intravenously after tumor exposure, and a special filter called YELLOW560 will be used on the operating microscope to see the fluorescent coloring of the contrast.

Intravenous administration 1 mg/kg initial dosing if insufficient additional doses of 1 mg/kg may be administered.

Integrated fluorescence module serves to make fluorescent areas visible to assist in visualizing tumor during the resection.

YELLOW560 filter

Matthew L Carlson, MD

The purpose of this study is to see if there is benefit to using an IV contrast called AK-Fluor® and a microscope filter called YELLOW560 when surgically removing a vestibular schwannoma, Meningioma, Head and Neck Paraganglioma, or Head and Neck Schwannoma.

Microscopic Fluorescence-guided Vestibular Schwannoma Resection Using Fluorescein Sodium and YELLOW 560

Microscopic Fluorescence-guided Vestibular Schwannoma, Meningioma, Head and Neck Paraganglioma, or Head and Neck Schwannoma Resection Using Fluorescein Sodium and YELLOW 560

Physician response to surgeon survey question, "Based on the use and performance of FS in this case alone, how likely are you to use FS in future cases (excluding the research trial) involving this tumor?" using a Likert-style rating from 0-4 where 0=Unsure; 1= Plan to not use in any cases; 2= Plan to use in select cases; 3=Plan to use in the majority of cases; 4=Plan to use in all cases.

Fluorescence correlate with surgeons' visual assessment of the tumor and nerve tissue under normal microscopy without the Yellow 560 filter using a Likert-style rating from 1-4 where 1=No correlation; 2=Some correlation; 3=Good correlation; 4=Excellent correlation.

Surgeons' assessment of fluorescence correlate with electrostimulation (e.g. tissues with high fluorescence do not stimulate, whereas nerve tissues with low fluorescence do stimulate)" using a Likert-style rating from 1-4 where 1=No correlation; 2=Some correlation; 3=Good correlation; 4=Excellent correlation.

The amount of time in minutes for differential visualization of the tumor and surrounding tissue after sodium fluorescein administration during surgery

Average dose of sodium fluorescein administered during surgery to achieve differential fluorescence of the tumor and tissue reported in mg/kg

Number of subjects to have a gross total resection

Mayo Clinic

Principal Investigator

Subjects undergoing clinically planned vestibular schwannoma, Meningioma, Head and Neck Paraganglioma, or Head and Neck Schwannoma, removal surgery will have contrast agent fluorescein sodium administered intravenously after tumor exposure, and a special filter called YELLOW560 will be used on the operating microscope to see the fluorescent coloring of the contrast.

Fluorescein Sodium: Intravenous administration 1 mg/kg initial dosing if insufficient additional doses of 1 mg/kg may be administered.

YELLOW560 filter: Integrated fluorescence module serves to make fluorescent areas visible to assist in visualizing tumor during the resection.

Fluorescein Sodium (FS) and YELLOW 560 nm Microscope Filter (YE560) During Surgery

Age, Continuous

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Matthew Carlson

Unsure

Plan to not use in any cases

Plan to use in select cases

Plan to use in the majority of cases

Plan to use in all cases

Surgeon Predicted Use of Fluorescein Sodium in Future Cases

No correlation

Some correlation

Good correlation

Excellent correlation

Correlation of Fluorescein Sodium With Surgeons' Visual Assessment

Correlation of Fluorescein Sodium With Electrostimulation

Time to Differential Visualization

Average Dose of Sodium Fluorescein Administration

Total Resection Rate

Heart and Blood Diseases

Cerebrovascular Disorders

Vascular Diseases

All patients enrolled in the study will prepare for surgery as per standard neurosurgical indications, procedures and institution protocols. At the time of the anesthesia induction, with the patient under general anesthesia, Fluorescein Sodium 10% (100mg/1mL) at a dose of 500mg (100mg/ml) will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used).

Conventional microsurgical and biopsy procedures and techniques including histopathology and intraoperative imaging will be performed through the completion of the surgery. The surgeon will resect and remove what he believes is the tumor based on previously known criteria (standards of care) regardless of what the Fluorescein angiography demonstrates. For vascular lesions, fluorescein sodium 10% (100mg/1mL) will be injected and used to assess its application after the conventional methods have confirmed the exclusion of the aneurysm. No patient's care will be affected by the results of the Fluorescein angiography.

Cherlynn Basignani, BSN,RN,CCRC

Gabriella Anderson, BA, CCRC

Ravi Gandhi, MD

This study focuses on implementing Yellow 560 for the direct intraoperative visualization of Fluorescein Sodium stained intracranial lesions to facilitate extend of surgery, develop better treatment protocols, and improve the prognosis of a wide array of neurosurgical diseases. More specifically, for the patients who are undergoing surgical intervention for the treatment of their brain aneurysm, tumor, arteriovenous malformation or fistula, the investigators will inject the dye intraoperatively to assess for residual aneurysm, tumor or in general residual lesion which must be corrected.

The research design is a prospective clinical study. All patients enrolled in the study will prepare for surgery as per standard neurosurgical indications, procedures and institution protocols. At the time of the anesthesia induction, with the patient under general anesthesia, Fluorescein Sodium 10% (100mg/1mL) at a dose of 500mg (100mg/ml) will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used). Surgery will continue with the aid of the Yellow 560 microscope with a minimum delay of 10 minutes after injection to reduce the amount of leakage of Fluorescein Sodium into the surrounding tissue.

Conventional microsurgical and biopsy procedures and techniques including histopathology and intraoperative imaging will be performed through the completion of the surgery. The surgeon will resect and remove what he believes is the tumor based on previously known criteria (standards of care) regardless of what the Fluorescein angiography demonstrates. For vascular lesions, fluorescein sodium 10% (100mg/1mL) will be injected and used to assess its application after the conventional methods have confirmed the exclusion of the aneurysm. No patient's care will be affected by the results of the Fluorescein angiography.

No other additional neurosurgical instruments will be used. Patients will be treated post-operatively with conventional adjunctive therapies and imaging as deemed necessary by the attending neurosurgeon for the evaluation of extent of surgery. Follow-up data (including post-operative images assessing outcomes and complications) will be collected on all patients on standard post-operative visits. Intra-operative films or recordings and all patient data may be saved and used according to HIPAA allowances.

The main outcome measure of the study would be a comparison between patient pre-operative and post-operative images to evaluate the potential utility of using Fluorescein Sodium and the Yellow 560 microscope to aid in the treatment of intracranial tumors and vascular lesions.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Yellow 560 Microscope for Intraoperative Visualization of Fluorescein Stained Intracranial Lesions	NCT02028325	Adult Intracran... Vascular: Intra...	Fluorescein Sod...	18 Years -	Indiana University
Yellow 560 Microscope for Intraoperative Visualization of Fluorescein Stained Intracranial Lesions	NCT02028325	Adult Intracran... Vascular: Intra...	Fluorescein Sod...	18 Years -	Indiana University
Identification of Nerves Using Fluorescein Sodium	NCT06054178	Pleomorphic Ade... Warthin Tumor Head and Neck D...	Fluorescein Sod...	18 Years -	Stanford University
Microscopic Fluorescence-guided Vestibular Schwannoma Resection Using Fluorescein Sodium and YELLOW 560	NCT04351373	Vestibular Schw...	Fluorescein Sod... YELLOW560 filte...	18 Years -	Mayo Clinic
Yellow 560 Microscope for Intraoperative Visualization of Fluorescein Stained Intracranial Lesions	NCT02478346	Cerebrovascular... Intracranial Ne...	Fluorescein Sod...	18 Years -	AdventHealth

Spots Global Cancer Trial Database for fluorescein sodium